Texas Medplast, LLC

Address:6630 ROXBURGH DR,Houston,TX,77041,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (2)

Premarket Exempt

Clear

Savvy Mask® Level 3 Surgical Face Mask - 00850025566131 Catalog Number :

Device Description : The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surg The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear loops to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex

Device Class : 2

Duns Number: 117718048

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Savvy Mask® Level 3 Surgical Face Mask - 00850025566162 Catalog Number :

Device Description : The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surg The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex